APA Gets Word Out to Congress, FDA

In preparation for the September 9 hearing before the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee, APA and AACAP issued a joint statement strongly supporting the establishment of a“ comprehensive registry for all clinical trials conducted in the United States.” The APA/AACAP joint testimony, which included an analysis of various studies prepared by Darrel Regier, M.D., APA's director of research, and his staff, is posted online at<www.psych.org/advocacy_policy/leg_res/apa_testimony/apa_aacap_clin_trials.pdf>.

APA Trustee-at-Large David Fassler, M.D., testified at the FDA hearings in mid-September. In addition, extensive written testimony, compiled by Regier, was submitted for the record. Fassler's testimony is posted at<http://psych.org/advocacy_policy/reg_comments/fdapsychopharma.pdf>, and Regier's testimony is posted at<http://psych.org/advocacy_policy/reg_comments/fdapsychopharmatestimony.pdf>.

In anticipation of the September 23 hearing before the Oversight and Investigations Subcommittee, at which FDA officials were the only invited witnesses, APA sent a letter to all senators and representatives noting that key elements of a balanced response from Congress should include the following: support for a national clinical trials database; support for federally funded research into SSRIs and possible suicidality in the child/adolescent population; support for additional education of medical professionals to ensure high-quality prescribing, with an offer to assist; and a caution about the chilling effects of a black-box warning on access to medications. APA's letter to Congress is posted online at<www.psych.org/advocacy_policy/reg_comments/LettertoHEC9-23-04.pdf>.

In anticipation of FDA action, APA sent a letter restating strong concerns about the matter to the FDA. The letter to the FDA is posted online at<www.psych.org/advocacy_policy/reg_comments/20040928LtrtoFDAreantidepressantlabelsforchildren.pdf>.